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NCT01272635 · ClinicalTrials.gov registry record · Phase 3
Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.
A Phase 3 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 607
- Enrollment target
NCT01272635: Completed Phase 3 study, sponsored by Milton S. Hershey Medical Center.
NCT01272635 is a Phase 3 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 607 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01272635, a Phase 3 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 607 participants
- Enrollment target
Study Summary
This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.
Primary Outcome
Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.
Interventions
- DRUG Azithromycin
- DRUG Prednisolone
- OTHER Placebo Azithromycin
- DRUG Placebo Prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 607 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01272635 record still lists
NCT01272635 is an interventional study that assigns participants to a tested intervention. The registered 607 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 4 interventions - of which Azithromycin is the first listed.
NCT01272635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01272635 about?
NCT01272635 is a clinical study titled "Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.". This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial...
What is the current status of trial NCT01272635?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 607 participants. The study started on 2011-03. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01272635?
The interventions under investigation include: Azithromycin (DRUG), Prednisolone (DRUG), Placebo Azithromycin (OTHER), Placebo Prednisolone (DRUG).
Who is sponsoring clinical trial NCT01272635?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01272635's enrollment target sits among peer trials
607 605th of 2000 higher than 1,395 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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